GSK update on current development status of the GSK/NIH Ebola vaccine candidate

18 October 2014

Issued: London UK

With the Ebola crisis in west Africa continuing, GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible.

Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the USA, UK and Mali, and further trials due to start in the coming weeks.

Initial data from the phase 1 trials are expected by the end of the year and if successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the three affected countries – Sierra Leone, Guinea and Liberia. If the vaccine candidate is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control.

Beyond this, we are working with the WHO, regulators and other stakeholders to determine how and when near term supplies of the Ebola vaccine could be made available for targeted vaccination of additional health care workers and other people at high risk of infection in the affected countrieswhere the impact would be most likely to limit the further spread of the epidemic. Its future use in mass vaccination campaigns will depend on whether the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large enough quantities can be made.

We are actively exploring with relevant organisations and partners all opportunities to accelerate the development of manufacturing at an industrial scale so that if the trials are successful, we will be in a position to significantly ramp up production of the vaccine candidate to help combat this or future Ebola outbreaks.

GSK acquired this Ebola vaccine candidate through the acquisition of a biotechnology company, Okairos, in May 2013 and has since been working with the US National Institutes of Health to develop this vaccine candidate in response to the threat of Ebola.